FDA 510(k) Application Details - K110746

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K110746
Device Name	Computer, Diagnostic, Programmable
Applicant	TOMTEC IMAGING SYSTEMS, GMBH EDISONSTRASSE 6 UNTERSCHLEISSHEIM D-85716 DE Other 510(k) Applications for this Company
Contact	INGE SCHEIDT Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/17/2011
Decision Date	05/24/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review